Colon Cancer Diagnosis With FAPI-PET Imaging

NCT ID: NCT07272772

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-10-31

Brief Summary

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Whole body CT is the primary imaging method in staging and follow-up of colon cancer. Conventional PET-CT with 18F-labeled fluorodeoxyglucose (18F-FDG) has its limitations and has a secondary role in colon cancer protocols. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targeting a protein that is overexpressed by cancer-associated fibroblasts presents a potential new PET imaging tool.

The objective of this prospective study is to evaluate diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with colon cancer. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with colon cancer in primary staging and when suspected recurrence. 100 patients with colon cancer are enrolled and PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Staging

Staging

Group Type EXPERIMENTAL

PET/CT ([F-18]FAPI-74)

Intervention Type DEVICE

PET/CT with FAPI-74 tracer is performed

Interventions

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PET/CT ([F-18]FAPI-74)

PET/CT with FAPI-74 tracer is performed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation
* Patients with primary colon cancer with potentially curable metastases
* Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance
* WHO performance score 0-2
* Patient signs informed consent form after receiving written information

Exclusion Criteria

* Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
* Patient is not able to understand purpose of study
* Medical conditions prohibiting whole body PET-CT
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saila Kauhanen

Role: PRINCIPAL_INVESTIGATOR

Turku PET Centre, Turku University Hospital

Locations

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Turku PET Centre, Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Saila Kauhanen

Role: CONTACT

+358503017010

Other Identifiers

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Colon-FAPI

Identifier Type: -

Identifier Source: org_study_id

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